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This study is being conducted to determine whether treatment of obstructive sleep apnea (OSA) in patients with chronic kidney disease (CKD) improves kidney function. Half of the participants will receive continuous positive airway pressure (CPAP) treatment for their OSA in addition to their regular CKD treatment, while the other half will only receive their regular CKD treatment.
Obstructive sleep apnea (OSA) and associated hypoxemia during sleep have been associated with a decline in kidney function. The abnormalities in kidney function associated with OSA have been improved by treatment of OSA with continuous positive airway pressure (CPAP), which is a common and effective therapy for OSA. Up to now, clinical research on the impact of OSA on kidney function has been performed on patients without CKD. This study will examine the impact of CPAP therapy on kidney function in patients with CKD.
CKD patients with OSA and nocturnal hypoxemia will be randomized into one of two groups where half will receive treatment of their OSA with CPAP and the other half will not. All participants will have kidney function monitored every 3 months for a year by measurement of serum creatinine and proteinuria. The change in estimated glomerular filtration rate (eGFR) and proteinuria between the two groups will be assessed to determine whether treatment of OSA improves kidney function in patients with CKD.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CPAP Therapy | Experimental | Participants will receive standard medical care for CKD as well as CPAP therapy for the duration of the study (1 year). |
|
| No CPAP | Placebo Comparator | Participants will receive standard medical care for CKD. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CPAP | Device | Participants randomized into the experimental CPAP therapy arm will receive CPAP in addition to their standard medical therapy for CKD. CPAP will be worn whenever the participant sleeps for the duration of the study. |
| Measure | Description | Time Frame |
|---|---|---|
| eGFR (estimated glomerular filtration rate) | Change in eGFR in CPAP group compared to control group. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| ACR (albumin/creatinine ratio) | Change in albumin/creatinine ratio (ACR) in CPAP group compared to control group. | 12 months |
| Pittsburgh Sleep Quality Index (PSQI) | The PSQI is a validated, self-reported questionnaire that measures subjective sleep quality by asking patients about difficulties initiating and maintaining sleep. The change in PSQI in CPAP group will be compared to control. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Patrick J Hanly, MD | University of Calgary | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33316238 | Derived | Rimke AN, Ahmed SB, Turin TC, Pendharkar SR, Raneri JK, Lynch EJ, Hanly PJ. Effect of CPAP Therapy on Kidney Function in Patients With Chronic Kidney Disease: A Pilot Randomized Controlled Trial. Chest. 2021 May;159(5):2008-2019. doi: 10.1016/j.chest.2020.11.052. Epub 2020 Dec 13. | |
| 30904853 | Derived | Rimke AN, Ahmed SB, Turin TC, Pendharkar SR, Raneri JK, Lynch EJ, Hanly PJ. Effect of CPAP therapy on kidney function in patients with obstructive sleep apnoea and chronic kidney disease: a protocol for a randomised controlled clinical trial. BMJ Open. 2019 Mar 23;9(3):e024632. doi: 10.1136/bmjopen-2018-024632. |
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| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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|
| No CPAP | Other | Participants randomized into the placebo comparator no CPAP arm will receive standard medical therapy for CKD. |
|
| 12 months |
| Epworth Sleepiness Scale (ESS) | The ESS is a self-reported questionnaire that measures subjective sleepiness. Patients are asked to rate the tendency to fall asleep in eight passive situations. The change in ESS in the CPAP group will be compared to control | 12 months |
| Kidney Disease Quality of Life questionnaire (KDQoL) | The KDQoL focuses on the health concerns of patients with chronic kidney disease26. This has been modified slightly, by omitting 2 questions that ask about dialysis, to make it suitable for the non-dialysis CKD population. The change in KDQoL in the CPAP group will be compared to control. | 12 months |
| D020919 |
| Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |